Recall Z-0051-2018 ยท REA High-Power Laser Light Show Projector
United Nuclear Scientific Supplies, LLC
United Nuclear Scientific High Power Handheld Lasers. Laser products
| Date | Aug 25, 2016 |
| Status | Terminated |
| Reason | Failure to comply with the laser class limitation listed in the performance standard for Specific Use Laser products. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | United Nuclear will bring defect into compliance by : The Center for Devices and Radiological Health (CDRH) understands that the CAP involving three units will consist of the following: 1. Notification will be given to purchasers per 21 CFR 1003.21. 2 .A full refund will be offered to all purchasers upon return of their laser pointers. 3. Postage paid shipping containers will be provided to all purchasers for the return of the laser pointers. Please note that United Nuclear Scientific Supplies, LLC is responsible for the correction of all noncompliant products If you have any questions |
| Quantity | 3 |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.